21 CFR 872.3680 - Polytetrafluoroethylene (PTFE) vitreous carbon materials.

§ 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.

(a)Identification. Polytetrafluoroethylene (PTFE) vitreous carbon material is a device composed of polytetrafluoroethylene (PTFE) vitreous carbon intended for use in maxillofacial alveolar ridge augmentation (building up the upper or lower jaw area that contains the sockets in which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth are rooted) or the temporomandibular joints (the joint between the upper and lower jaws).

(b)Classification. Class II.

[ 52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987]

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 872 after this date.

  • 2015-11-20; vol. 80 # 224 - Friday, November 20, 2015
    1. 80 FR 72585 - Dental Devices; Reclassification of Electrical Salivary Stimulator System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective December 21, 2015.
      21 CFR Part 872